Abstract：OBJECTIVE To discuss the technical requirements of scored tablets combining with the current situation of clinical use of scored tablets and the domestic and national technical requirements. METHODS The FDA guidance on tablet scoring was introduced in detail, on this basis, the general considerations on the technical requirements of generic scored tablets were put forward. RESULTS AND CONCLUSION It was suggested that the evaluation criteria should be established on the basis of taking a full consideration on product characteristics in the process of research and development, scored tablets should be developed in accordance with clinical needs, and specification description should be standardized for clarifying the clinical use of the scored tablets.
罗俊永, 陈蒙蒙, 朱雪萍. 浅谈刻痕片的临床使用与技术要求[J]. 中国药学杂志, 2020, 55(3): 245-248.
LUO Jun-yong, CHEN Meng-meng,ZHU Xue-ping. Discussion on Clinical Use and Technical Requirements of Scored Tablets. Chinese Pharmaceutical Journal, 2020, 55(3): 245-248.
QUINZLER R, GASSE C, SCHNEIDER A, et al. The frequency of inappropriate tablet splitting in primary care[J]. Eur J Clin Pharm, 2006, 62(12):1065-1073.
[2]
LIU N N, HAN Y Y, WANG X X, et al. Statistics and analysis of splitting use of oral tablets in the inpatients of our hospital in Jan. 2016[J]. J China Pharm(中国药房), 2017, 28(10):1434-1437.
[3]
SHANG G M, ZHAO R W. Analysis of splitting use of prescription minimum specifications in our hospital [J]. Northwest Pharm J(西北药学杂志), 2005, 20(4):175-176.
[4]
WU J Q, YANG Y X, LV Z J. Investigation on the use of splitting tablet in inpatient pharmacy of our hospital and continuous quality improvement [J]. Pract Pharm Clin Remed(实用药物与临床), 2018, 21(2):235-237.
[5]
ZHOU S Q, WEI L H, ZHOU D Q. The investigate of microbial pollution and weight difference of six scored tablets in ward pharmacy [J]. Anti-Infec Pharm(抗感染药学), 2009, 6(2):123-124.
[6]
National Medical Products Administration. Guidance for chemical pharmaceutical preparations research[Z]. 2005.
[7]
EP 9.7 [S]. 2019: 4790.
[8]
FDA. Scoring Configuration of Generic Drug Products [Z]. 1995.
[9]
FDA. Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation [S]. 2013.
[10]
YAO G X, TANG Y L. The accuracy comparion of different shape scored tablets [J]. China Pharm(中国药业), 2007, 16(14):49.
[11]
VANDER STEEN K C, FRIJLINK H W, SCHIPPER C M, et al. Prediction of the ease of subdivision of scored tablets from their physical parameters[J]. AAPS Pharm Sci Tech, 2010, 11(1):126-132.
2020, Vol. 55 
